Exhibit
10.1


 


 


RESEARCH
COLLABORATION AGREEMENT


 


This
Agreement is between the National Center for Advancing Translational Sciences (“NCATS”), which is a component of the
National Institutes of Health (“NIH”), an agency of the U.S. Department of Health and Human Services, having offices
located at 9800 Medical Center Drive, Rockville, MD 20850, and Regen Biopharma, Inc. (“Collaborator”), having a principal
place of business at 4700 Spring Street, Suite 304, La Mesa, CA 91942 (collectively, the “Parties”). This Agreement
is neither a funding agreement as defined in 35 U.S.C. § 201(b) nor a cooperative research and development agreement authorized
under the Federal Technology Transfer Act of 1986, as amended, 15 U.S.C. §§ 3710a et seq., and Executive Order
12591 of April 10, 1987. NCATS enters into this Agreement pursuant to the authority of the Public Health Services Act of 1944,
as amended (42 U.S.C. § 241).


 


Background


		1.	NCATS
                                         and Collaborator want to collaborate on a research project; and



		2.	NCATS
                                         and Collaborator want to transfer between the laboratories of their investigators, during
                                         the term of this Agreement, confidential information and proprietary research materials
                                         required to conduct the research project.



 


Terms
and Conditions


 


Article
1DEFINITIONS


		1.1	“Confidential
                                         Information” includes scientific, business, or financial information pertaining
                                         to the Research Project (defined below) that is designated as confidential by Provider
                                         (defined below). Confidential Information does not include information that: (i) is in
                                         the public domain other than as a result of a disclosure by Recipient (defined below)
                                         or any of Recipient’s representatives in violation of this Agreement; (ii) was
                                         in the possession of Recipient before disclosure by the Provider; (iii) is acquired by
                                         Recipient from a third party having no obligation of confidentiality to Provider; (iv)
                                         is hereafter independently developed by Recipient, without reference to Confidential
                                         Information received from Provider; or (v) Provider expressly authorizes Recipient to
                                         disclose.



		1.2	“Invention”
                                         means any invention or discovery that is or may be patentable or protectable under applicable
                                         laws.



		1.3	“Investigator”
                                         means the principal researcher designated by a Party to direct the Research Project.



		1.4	“Material”
                                         means compounds and cell lines listed in Appendix A.



		1.5	“Progeny”
                                         means unmodified descendent from Material, such as virus from virus, cell from cell,
                                         or organism from organism.



		1.6	“Provider”
                                         means the Party that provides Material or discloses Confidential Information to the other
                                         Party under this Agreement.



		1.7	“Recipient”
                                         means the Party that receives Material or Confidential Information from the other Party
                                         under this Agreement.



		1.8	“Research
                                         Project” means the collaborative research described in Appendix A.



 







Article
2COLLABORATIVE RESEARCH


		2.1	NCATS
                                         and Collaborator agree to collaborate on the Research Project. The Investigator for NCATS
                                         will be Menghang Xia and the Investigator for Collaborator will be Harry M. Lander.



		2.2	Nothing
                                         in this Agreement will be construed to limit the freedom of either Party from engaging
                                         in similar research with other parties, providing the research does not create a conflict
                                         with the Parties’ obligations under this Agreement, especially with regard to Article
                                         3.



		2.3	The
                                         Parties recognize that the Research Project describes the collaborative research to be
                                         conducted under this Agreement and that the goals set forth in Appendix A are good faith
                                         guidelines. If events occur that require substantial modification of the Research Project,
                                         the Parties may amend Appendix A according to Paragraph 6.2.1 of this Agreement.



 


Article
3CONFIDENTIALITY; PUBLICATIONS


3.1Confidential
Information


	3.1.1	Either
                                         Party may disclose or receive Confidential Information under this Agreement.



	3.1.2	All
                                         Confidential Information exchanged between the Parties must conspicuously bear the words
                                         “Confidential Information” or “Confidential.” Confidential Information
                                         exchanged orally or through observation must be reduced to writing and marked “Confidential
                                         Information” or “Confidential” within 30 days after disclosure to be
                                         considered Confidential Information.



	3.1.3	Recipient
                                         will maintain Confidential Information in confidence for a period of 3 years from the
                                         effective date of this Agreement and will protect Confidential Information with the same
                                         degree of care as Recipient uses to protect its own Confidential Information.



	3.1.4	Recipient
                                         may disclose Confidential Information to its employees, consultants, or contractors to
                                         whom it is necessary to disclose this information for the purpose of the Research Project;
                                         Recipient may make these disclosures only under terms at least as restrictive as those
                                         specified in this Agreement. Recipient agrees that disclosure of Confidential Information
                                         may not be made to any party not listed herein unless Provider grants prior written approval
                                         to Recipient.



	3.1.5	Recipient
                                         may disclose Provider’s Confidential Information if required to do so by law, regulation,
                                         or court order. If Recipient, or anyone to whom it discloses Confidential Information
                                         in accordance with Article 3, becomes legally required to disclose any Confidential Information,
                                         Recipient will provide timely notice to Provider and, to the extent practicable, consult
                                         with Provider prior to any disclosure.



	3.1.6	Either
                                         Party may disclose the Abstract of the Research Project (in Appendix A) to the public.



3.2Publications;
Press Releases


	3.2.1	Publications



	3.2.1.1	In
                                         addition to the specific goals of the Research Project, the Parties view dissemination
                                         of research findings, both by publication and oral presentation, as an essential objective
                                         of the Research Project. Authorship will be decided according to commonly accepted conventions
                                         for scientific publications.



	3.2.1.2	The
                                         Parties are encouraged to make publicly available the results of the Research Project.
                                         Before either Party submits a paper or abstract for publication or otherwise intends
                                         to publicly disclose information about any Invention made in the course of the Research
                                         Project, the other Party will have 30 days to review proposed manuscripts and 3
                                         days to review proposed abstracts to assure that its Confidential Information is protected.
                                         Either Party may request in writing that the proposed publication or other disclosure
                                         be delayed for up to 30 additional days as necessary to file a patent application.



	3.2.2	Press
                                         Releases



		Neither party will,
                              without written consent of the other party, issue press releases that reference or rely upon the
                              Research Project under this Agreement, permission of which will not be unreasonably withheld. Press
                              release shall be provided by the releasing party at least 7 days prior to publication.



 


Article
4INVENTIONS; DATA


4.1Inventions


	4.1.1	The
                                         Parties acknowledge the possibility that Inventions may be made in the course of the
                                         Research Project. Inventorship of those Inventions will be determined in accordance with
                                         applicable U.S. laws and regulations. The term made, as used in reference to any invention,
                                         means the conception or first actual reduction to practice of such invention.



	4.1.2	Inventions
                                         made in the course of the Research Project will be owned by the Party employing the inventor
                                         or inventors. Inventions that are invented jointly by employees of both Parties will
                                         be owned jointly.



	4.1.3	Each
                                         Party will report to the other Party, in writing, all Inventions made during the Research
                                         Project no later than 3 months from the time the invention is disclosed to a Party by
                                         its Investigator. The reports will be written in sufficient detail to determine inventorship
                                         and will be treated as Confidential Information in accordance with Article 3. The Parties
                                         will confer with each other regarding a patent filing strategy for jointly made Inventions.
                                         If either Party files a patent application on a jointly made Invention, then the filing
                                         Party will include a statement in the patent application that clearly identifies the
                                         Parties and states that the Invention was made jointly under this Agreement. The Parties,
                                         moreover, agree to enter into an inter-institutional agreement with respect to Joint
                                         Inventions, which shall authorize Collaborator to have primary control and responsibility
                                         for any patenting and commercialization activities and shall be negotiated in good faith
                                         based on the respective parties’ contributions to each Joint Invention.



4.2Data


			Each
                                         Party will disclose to the other Party a summary of all data generated under this Agreement.
                                         Subject to the restrictions in Article 3, both Parties will have free access to and use
                                         of any data generated under this Agreement.



 


Article
5THE TRANSFER AND USE OF MATERIAL


5.1Mechanics
of Transfer


			Either
                                         Party may provide or receive Material under this Agreement. Provider will send Material
                                         to Recipient with a cover letter as described in Appendix B. The letter will refer to
                                         this Agreement and identify Material. If either Party transfers to the other Party a
                                         material not listed in Appendix A, the Parties will amend this Agreement to include the
                                         additional material.



5.2Conditions
of Use


	5.2.1	RECIPIENT
                                         WILL NOT USE MATERIAL IN RESEARCH INVOLVING HUMAN SUBJECTS.



	5.2.2	Recipient’s
                                         Investigator will use Material solely in connection with the Research Project in the
                                         Investigator’s laboratory. If Recipient wants to use Material for commercial purposes,
                                         Recipient agrees to first obtain the appropriate commercial use or commercialization
                                         license from Provider.



	5.2.3	Recipient
                                         agrees that Recipient’s Investigator will retain control over Material and further
                                         agrees that Recipient’s Investigator will not transfer Material to people not under
                                         the Investigator’s direct supervision without advance written approval of Provider.



	5.2.4	Recipient
                                         will use Material in compliance with all applicable laws, regulations and policies.



	5.2.5	Provider
                                         reserves the right to distribute its Material to others and to use its Material for its
                                         own purposes.



	5.2.6	Upon
                                         termination of this Agreement, Recipient agrees that Recipient’s Investigator will
                                         return any and all remaining Material unless Provider gives Recipient’s Investigator
                                         directions for disposing of Material by another means.



	5.2.7	Nothing
                                         in this Agreement will be construed as conferring on Recipient any implied license to
                                         Material, or option to license Material, any technology, or any patent or patent application
                                         owned by Provider and will not create any obligation, by implication or otherwise, of
                                         either Party to enter into any further agreement with the other Party.



 


Article
6TERMINATION AND GOVERNANCE


6.1Effective
Date


This
Agreement will be effective on the date of the last authorized signature below.


6.2Term
and Termination


	6.2.1.	The
                                         Parties agree that this Agreement will be effective for 3 years from the date of the
                                         last authorized signature below and may be extended as mutually agreed by the Parties
                                         in a written amendment to this Agreement.



	6.2.2	This
                                         Agreement will terminate immediately upon the mutual agreement of the Parties in writing.



	6.2.3	This
                                         Agreement will terminate in 30 days after either Party receives written notice of the
                                         other Party’s desire to terminate this Agreement.



6.3Representations,
Warranties, and Liability


	6.3.1	Material
                                         is understood to be experimental in nature and may have hazardous properties. MATERIAL
                                         IS BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
                                         WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Provider makes no representations
                                         that the use of Material will not infringe any patent or other proprietary rights of
                                         third parties.



	6.3.2	No
                                         indemnification for any loss, claim, damage, or liability is intended or provided by
                                         either Party under this Agreement. Each Party will be liable for any loss, claim, damage,
                                         or liability that the Party incurs as a result of its activities under this Agreement,
                                         except that NCATS, as an agency of the U.S. Government, assumes liability only to the
                                         extent provided under the Federal Tort Claims Act, 28 U.S.C. §§ 2671 et
                                         seq.



6.4Assignment


Neither
this Agreement nor any rights or obligations of either Party hereunder may be assigned or otherwise transferred by either Party
without the prior written consent of the other Party. This Agreement will be binding upon the Parties and their respective successors
and permitted assigns.


6.5Non-endorsement


By
entering into this Agreement, NCATS does not directly or indirectly endorse any product or service that is or will be provided,
whether directly or indirectly related to this Agreement, by Collaborator, its successors, permitted assigns, or licensees. Collaborator
will not in any way state or imply that this Agreement is an endorsement of any such product or service by the U.S. Government
or any of its organizational units or employees.


6.6Survivability


Articles
3, 4, 6.3, 6.5, 6.6 and 6.8 will survive expiration or earlier termination of this Agreement.


6.7Severability


The
illegality or invalidity of any provisions of this Agreement will not impair, affect, or invalidate the other provisions of this
Agreement.


6.8Governing
Law


The
construction, validity, performance, and effect of this Agreement will be governed by federal law as applied by the federal courts
in the District of Columbia. Federal law and regulations will preempt any conflicting or inconsistent provisions in this Agreement.


6.9Entire
Agreement


This
Agreement, together with all appendices, constitutes the entire agreement between the Parties and supersedes any prior or contemporaneous
oral or written agreements or communications between them with respect to the subject matter hereof. This Agreement may be amended
only by written instrument signed by authorized representatives of NCATS and Collaborator.


6.10         
Notices


All
notices pertaining to or required by this Agreement shall be in writing, shall be signed by an authorized representative and shall
be delivered to the addresses indicated on the signature page for each Party.


 


 


 


 


SIGNATURES
BEGIN ON THE NEXT PAGE



FOR
NCATS:


 


 





	/s/ Lila Portilla	 	12/15/2015
	Lili M. Portilla, MPA	 	Date
	Director, Office of Strategic Alliances, NCATS	 
	 	 	 
	Mailing Address for Notices:	 
	Lili M. Portilla, MPA	 
	National Center for Advancing Translational Sciences, NIH	 
	9800 Medical Center Drive, Room B 311	 
	Bethesda, MD 20892-3370	 
	Phone: 301-217-2589	 
	Fax: 301-217-5736	 






 


Acknowledgment
by NCATS’s Investigator:


 


 





	/s/ Menghang Xia	 	12/16/2015
	Menghang Xia, Ph.D.	 	Date
	Group Leader, Toxicology, NCATS	 	 
	 	 	 
	 	 	 



 





FOR
COLLABORATOR:


 





	/s/ Harry Lander	 	12/15/2015
	Harry Lander, Ph. D.	 	Date
	President and Chief Scientific Officer, Regen Biopharma, Inc.	 
	 	 	 
	Mailing Address for Notices:	 
	Harry Lander, Ph.D.	 
	Regen Biopharma, Inc.	 
	President and Chief Scientific Officer	 
	4700 Spring Street, Suite 304	 
	La Mesa, CA 91942	 
	917-696-1991	 
	Harry.Lander@regenbiopharma.com	 






 


 


Acknowledgment
by COLLABORATOR’s Investigator:


 


 





	/s/ Harry Lander	 	12/15/2015
	Harry M. Lander	 	Date
	President and Chief Scientific Officer	 
	 	 	 
	 	 	 








    	 



    	 



    

APPENDIX
A


 


Research
Project Summary


 


I.
Abstract of the Research Project – for Public Release


Either
party may, without further consultation or permission, release this abstract to the public.


Project
Title: Identification of possible ligands for the NR2F6 orphan nuclear receptor.


 


Project
Abstract: These studies are designed to screen for small molecule compounds that activate or inhibit the orphan nuclear receptor,
NR2F6. Small molecule compounds from the NCATs compound libraries will be screened against cell lines expressing either the ligand
binding domain or the full length protein of NR2F6 fused to a luciferase-based reporter construct and stably expressed in HEK293
cells.


 


 


II.
Goal(s) of Project: To identify possible ligands for the NR2F6 orphan nuclear receptor by screening
the reporter gene assay of NR2F6 cell lines using known compound libraries, NPC and LOPAC. Such ligands that show specificity
for NR2F6 may lead to the development of novel immunotherapy treatments. 


 


 


III.
Background: The immunotherapy of cancer has completely changed the clinical management of various
tumors and has dramatically improved the survival rates in those people with melanoma and lymphoma. The key discovery of this
field was the identification of immune checkpoints – molecules whose expression leads to the shutting down of the immune
system’s natural ability to kill cancerous cells. There are currently three checkpoint proteins that have been identified
and for which there are now clinically useful drugs which target these. All of these proteins are expressed as cell surface proteins
and the treatments involve injection of antibodies to these proteins.


 


Regen
has identified a nuclear receptor, NR2F6, which has properties very much like the known checkpoint proteins. So far, the only
ways to inhibit this receptor include the use of gene silencing techniques or knock outs in mice. Identification of a small molecule
which could inhibit this receptor would potentially provide a major new avenue for immunotherapy of cancer.


 


 


IV.
Respective Contributions of the Parties


 


Material
Contributed by NCATS: NPC and LOPAC compound libraries will be used to screen this receptor
at NCATS. 


 


Material
Contributed by Collaborator: NR2F6 orphan nuclear receptor cell lines will be provided by Regen.
These lines will be HEK293 lines stably expressing NR2F6 ligand binding domain or the full-length NR2F6 protein as well as a positive
control line expressing the estrogen receptor. Each of these target nuclear receptors will be fused to a luciferase-based reporter
gene assay vector.


 


 


V.
Experimental Plan: Cell lines (LBD, Full-length and positive control ER) will be transferred
onto screening robotic system. Compound libraries will be screened at various concentrations. After the primary screening, the
potential hits will be cherry-picked and confirmed in the follow up studies.  


 



    

    

    








APPENDIX
B


 


Sample
Material Transfer Cover Letter


 


A
sample letter follows.


 


Date


 


Provider
Organization Name


Provider
Organization Address


Tel:


Fax:


 


Recipient
PI


Recipient
Organization


Recipient
Organization Address


 


		RE:	Transfer
                                         of Material(s) under Collaboration Agreement between NCATS and [name of Collaborator]
                                         dated [month/year]



 


 


Dear
Dr. [Name of NCATS PI or Collaborator PI]:


 


The
[NCATS or Collaborator] is pleased to provide you with the following material: [Describe material]. The material developed by
[insert name], are being shipped to you by [NCATS/Collaborator].


The
material may only be used for research conducted between NCATS and [Collaborator] under the Collaboration Agreement referenced
above. In addition, you understand that any remaining material will be returned to [NCATS/Collaborator] or disposed of according
to the written instructions of [NCATS/Collaborator] when the Collaboration Agreement expires, unless [NCATS/Collaborator] obtains
permission from [NCATS/Collaborator] to continue using the materials.


Please
acknowledge receipt of the material(s) by signing below. At your earliest convenience, please fax a copy of this letter to your
technology transfer office at [NCATS/Collaborator].


 


Sincerely,


 


 


NCATS/Collaborator
[Provider]


Title


cc:


 


Acknowledged
by NCATS/Collaborator PI [Recipient]


 





	 	 	 
	Signature	 	Date
	 	 	 
	 	 	 
	Printed Name and Title	 	 



 


 





SignatureDate


 





Printed
Name and Title